Proposal
      for Clinical Trial Services to Support Transdel Pharmaceuticals Inc.’s
      Ketotransdel for the Treatment of Mild to Moderate Acute Soft Tissue
      Injury

    


    


    Prepared
      for: 

    

    4225
      Executive Square Suite 460

    La
      Jolla,
      CA 92037 

    


    


    Revised:
      10 June 2008

    


    


    Prepared
      by:

    Cato
      Research Ltd.

    


    
      	
               

              Research
                Triangle Park, North Carolina

              Westpark
                Corporate Center

              4364
                South Alston Avenue

              Durham,
                NC 27713

              Phone:
                919-361-2286

            	
               

              Montreal,
                Canada

              9900
                Cavendish Boulevard, Suite 400

              St.-Laurent,
                Québec

              Canada
                H4M 2V2

              Phone:
                514-856-2286

            	
               

              Boston,
                Massachusetts

              Bay
                Colony Corporate Center

              1100
                Winter Street

              Waltham,
                MA 02451 

              Phone:
                781-890-4477

            
	 	 	 
	
              Northern
                California

              601
                Gateway Boulevard, Suite 1010

              South
                San Francisco, CA 94080 

              Phone:
                650-588-8256

            	
              Southern
                California

              6480
                Weathers Place, Suite 104

              San
                Diego, CA 92121

              Phone:
                858-452-7271

            	
              Washington,
                D.C., metro

              9605
                Medical Center Drive, Suite 390

              Rockville,
                MD 20850 

              Phone:
                301-309-1260

            
	 	 	 
	
              Tel
                Aviv, Israel

              2,
                Habarzel Street, 4th floor

              Ramat
                Hahayal

              Tel
                Aviv, Israel 69710

              Phone:
                9723-644-9522

            	
              Riga,
                Latvia

              Studika
                Monitoring + Audit GmbH

              Poruka
                iela 8

              LV
                1014 Riga

              Phone:
                +37-19512220

            	
              Frankfurt
                am Main, Germany

              Staufenstrasse
                4

              60323
                Frankfurt am Main, Germany

              Phone:
                +49-69-972-64550

            
	 	 	 
	
              Johannesburg,
                South Africa

              1st
                Floor Building 27

              Waterford
                Office Park

              Waterford
                Drive, Fourways 2055

              Johannesburg,
                South Africa

              Phone:
                +27-11-658-8400

            	
              Cologne,
                Germany

              Studika
                Monitoring + Audit GmbH

              Hertzstrasse
                7

              D-50859
                Köln

              Cologne,
                Germany

              Phone:
                +49-2234-70672

            	
              Graz,
                Austria

              JSW-Research

              Forschungslabor
                GmbH

              Rankengasse
                28

              8020
                Graz, Austria

              Phone:
                +43-316/765114-11

               

            


    

    


    


    www.cato.com

     

    
      	Strategies.
              Solutions. Success. TM	
               

            


    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	CONFIDENTIAL	
              Cato
                Research Ltd.

            
	 	 


    

     

     

    Overview
      of the Proposal

     

     

     

    
      	
              

              When
                it comes to developing human therapeutics, Cato Research relies on
                sound principles of science and medicine.

            	
              This
                proposal is organized into the following parts:

               

              Part
                A 

               

              ·  Introduction
                to Cato Research and Summary of Activities 

               

              Part
                B

               

              ·  Experience
                in Neurology Clinical Trials

               

              Part
                C

               

              ·  Terms
                of Work

               

              Appendix
                1

               

              ·  Project
                Timelines and Project Assumptions

              ·  Summarized
                and Details of Costs, Estimated Pass Through Expenses, Estimated
                Milestone
                Completion Dates, and Fees Associated with Milestones

               

               

               

               

               

               

            
	
              This
                proposal has been prepared based on information provided by Transdel
                Pharmaceuticals, Inc. and Cato Research’s experience with similar
                projects. It is available to Transdel Pharmaceuticals for 45 days
                from the
                date of issuance. The proposal constitutes Cato Research confidential
                information and should not be disclosed to any third party without
                Cato
                Research’s prior written consent.

            


    

     

    
      
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                  Research Ltd.

              
	 	 


      

       

    

    
      	
               

              Part
                A

               

              Introduction
                to Cato Research 

              and
                Summary of Activities 

               

            


    

     

    
      
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        	CONFIDENTIAL	
                Cato
                  Research Ltd.

              
	 	 


      

    

     

    Overview
      of Cato Research

     

    
      	
               

               

               

              Cato
                Research specializes in complex development programs requiring innovative
                regulatory and clinical strategies for pharmaceutical, biotechnology,
                and
                medical device companies.

               

               

               

            	
              Organization

               

              Cato
                Research is a full-service CRO offering integrated drug development
                services, including clinical trial support and regulatory and product
                development strategy for drugs, biologics, diagnostics, and medical
                devices. Our staff has medical and scientific expertise necessary
                for the
                successful conduct of development programs across many different
                therapeutic areas and in multiple locations worldwide. We have offices
                in
                strategic locations around the world, as indicated on the cover page.
                Our
                staff members have relevant and diverse backgrounds, including previous
                experience in the pharmaceutical industry, biotechnology companies,
                academia, as well as basic and clinical research programs.

               

              Regulatory
                Services

               

              ·  Strategic
                consulting

              ·  Integrated
                development plan preparation

              ·  Pre-Investigational
                New Drug application (IND) and pre-investigational device exemption
                meeting package preparation and meeting conduct

              ·  IND
                preparation and submission (common technical document and electronic
                common technical document format)

              ·  Marketing
                application writing and submission

              ·  Regulatory
                agency interactions

              ·  Chemistry,
                manufacturing, and controls program management

              ·  Nonclinical
                program design and management

               

              Clinical
                Trial Services

               

              ·  Protocol
                and case report form (CRF) design

              ·  Regulatory
                application preparation and submission

              ·  Clinical
                monitoring and management

              ·  Medical
                monitoring and pharmacovigilance

              ·  Data
                management, including electronic data capture (EDC)

              ·  Statistical
                analysis and clinical study report writing

              ·  Project
                management

               

              Primary
                Therapeutic Areas 

               

              ·  Neurology

              ·  Oncology

              ·  Cardiology

            
	
               

              Founded
                in 1988, Cato Research has earned a reputation for speed and
                efficiency without sacrificing quality.

               

               

               

            
	
               

              Through
                strategic growth, Cato Research is positioned as a midsize CRO in
                key
                North American and international markets. Focusing on our core expertise
                in regulatory strategy, project management, and clinical trial management,
                we offer integrated development services and solutions from discovery
                to
                postmarketing.

            
	
              Our
                experienced, multidisciplinary project teams take pride in their
                work and
                use established project management processes to provide flexible,
                responsive, and personalized services in collaboration with our
                sponsors.

               

            


    

     

    
      
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        	CONFIDENTIAL	
                Cato
                  Research Ltd.

              
	 	 


      

       

    

    Cato
      Research’s Clinical Strategies and Solutions

     

    Cato
      Research appreciates the opportunity to provide a proposal for services to
      support Transdel’s protocol entitled, “A Randomized, Multicenter, Double-Blind,
      Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and
      Safety of KetotransdelTM (Ketoprofen Topical Cream 10%) in the Treatment of Mild
      to Moderate Acute Soft Tissue Injury” 

     

    Cato
      Research understands that Transdel is interested in the following
      services:

     

    Clinical
      Trial Preparation:
      including preparation of trial documents and monitoring plan, project-related
      meetings, and project-specific training

     

    Clinical
      Trial Conduct:
      including all site visits, medical monitoring, and medical coding

     

    Pharmacovigilance:
      including setup of an Argus Safety database and processing of all serious
      adverse events (SAEs) during the study

     

    Data
      Management (etrials®):
      including project initiation, development of an electronic CRF (eCRF), edit
      checks, and server implementation, investigator training, data project
      management, data archiving, and study closeout 

     

    Statistics:
      including production of final data displays, listings, summary tables, and
      figures

     

    Clinical
      Study Reports:
      including preparation of the clinical study report and appendices in electronic
      format

     

    Regulatory:
      including ongoing tracking and management of study-related regulatory
      documentation

     

    Project
      Management:
      including preparation of project work plans, timelines, budgets and study
      reports; internal team meetings to monitor project progression; creation of
      tracking reports; and document management of files

     

    Sponsor
      Interactions:
      including routine monthly conference calls to discuss project status and
      development issues

     

    A
      comprehensive, itemized list of all proposed activities and their costs is
      provided in Part C of this proposal. 

     

    
      
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                    Research Ltd.

                
	 	 


        

      

       

    

    Cato
      Research is an experienced provider of high-quality clinical trial services:
      from protocol development and site selection to clinical monitoring,
      pharmacovigilance services and biostatistical analysis. Cato Research can
      support the timely and cost-effective development of Ketotransdel. As a midsize
      CRO, we are able to offer our sponsors personal attention as well as access
      to
      the expertise of our senior management. 

     

    We
      have
      highlighted a few areas here that embody our unique perspective on management
      of
      clinical studies.

     

    Project
      Management

     

    We
      are a
      matrix organization that draws members from various operational groups to staff
      a project team with specific emphasis on matching project needs with expertise.
      We believe it is important for our project managers to have a comprehensive
      understanding of the clinical trial environment. As such, many of our project
      managers are Ph.D.-level scientists, have obtained certified clinical research
      professionals (C.C.R.P.) certifications, are regulatory affairs certified
      (R.A.C.), or are certified project management professionals (P.M.P.). In
      addition to having project management responsibilities, our project managers
      can
      also author and review protocols, development plans, and regulatory
      documentation. It is our experience that this advanced training and
      comprehensive knowledge of the dynamic development environment give Cato
      Research project teams the ability to maximize creative strategies and solutions
      while at the same time, remaining time- and cost-efficient.

     

    Our
      project teams are led by experienced project managers, overseen by a program
      director, a senior staff member who provides expertise and guidance as
      necessary, and supported by a project coordinator, who handles the day-to-day
      tracking and logistical activities.

     

    Cato
      Research believes that effective project management begins at project
      initiation. We recommend development of a detailed project plan, including
      a
      communications plan, in conjunction with our sponsors to set expectations,
      establish communication flow, and outline project tracking methods. We also
      recommend holding a face-to-face kick-off meeting to define the project scope,
      priorities, and timelines.

     

    Clinical
      Management

     

    Cato
      Research offers experienced monitoring teams with strong health care
      backgrounds. Many of our clinical research associates (CRAs) and clinical study
      managers (CSMs) are nurses, have earned C.C.R.A. accreditation, or have earned
      EDC certification. We have strong internal continuing education programs for
      our
      clinical staff, including a yearly clinical conference, monthly trainings on
      selected key topics, and ongoing study groups.

     

    For
      our
      teams to function in the most efficient and cost-effective manner, we have
      divided some tasks traditionally seen as a CRA role into an in-house CSM role
      with the following responsibilities:

     

    
      
        	
              	·	
                Conceptualizing
                  and evaluating study strategies with input from appropriate Cato
                  Research
                  project team members

              


      

    

     

    
      
        	
              	·	
                Reviewing
                  the progress of the Cato Research project team and resolving technical
                  and
                  interpersonal issues

              


      

    

     

    
      
        	
              	·	
                Providing
                  technical and administrative
                  leadership

              


      

    

     

    
      
        	
              	·	
                Coordinating
                  and planning project
                  deliverables

              


      

    

     

    
      
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                  Research Ltd.

              
	 	 


      

       

    

    
      
        	
              	·	
                Communicating
                  with program director and Cato Research senior management on study-related
                  issues that require additional
                  input

              


      

    

     

    
      
        	
              	·	
                Initiating
                  and maintaining effective and efficient communication with the
                  Cato
                  Research project team and with Transdel in order to ensure activities
                  meet
                  predefined timelines 

              


      

    

     

    
      
        	
              	·	
                Verifying
                  that effective and efficient communication and follow-up is occurring
                  between CRAs, investigative sites, Transdel, and any other contracted
                  organizations (e.g., core
                  lab)

              


      

    

     

    Having
      the CRA function as the primary site contact and the CSM function as the
      in-house contact allows more consistency with study activities, providing the
      sites with another contact and overall consistency for the study.

     

    Clinical
      Monitoring

     

    At
      each
      pre-study site selection visit, the Cato Research CRA will spend 4 hours on-site
      to confirm that facilities are appropriate and that the site staff is qualified
      to conduct this clinical study. 

     

    Each
      site
      initiation visit will include 8 hours on-site. We recommend conducting the
      site
      initiation visit after investigational product is received at the site to
      confirm that the site is ready to begin subject enrollment. Cato Research
      welcomes participation by a Transdel representative at this visit.

     

    During
      the 8-hour periodic site visits, the Cato Research CRA will conduct 100% source
      document verification of CRFs, perform drug-accountability activities, and
      review the regulatory site files to verify compliance (e.g., confirming that
      each subject has an informed consent form on file). Cato Research
      recommends that the first monitoring visit occur immediately after the first
      subject is treated at each site. This schedule enables identification of any
      data issues early in the study. The Cato Research CRA will collect completed
      CRFs from the site for data verification, the CRA or the site will enter the
      CRFs into the EDC database, and will work with data management and the site
      to
      resolve any data queries. For site visits performed remotely, the Cato Research
      monitors will review data by using the EDC system. Following patient visits,
      sites will forward the source documents to Cato Research for verification.
      

     

    At
      the
      conclusion of the study, Cato Research will conduct an 8-hour closeout visit
      at
      each study site. We recommend conducting this visit when almost all queries
      are
      resolved so that all site activities can be closed out at this time. The CRA
      will perform final study activities such as drug reconciliation/accountability
      and final regulatory document review at this visit.

     

    Each
      visit will be performed according to Cato Research SOPs. After each visit,
      the
      CRA will prepare a monitoring trip report that uses Cato Research’s standard
      format. The report will be reviewed by the CSM before being delivered to
      Transdel.

     

    
      
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                    Research Ltd.

                
	 	 


        

         

      

    

    Medical
      Management and Pharmacovigilance

     

    Our
      medical team is supported by a dedicated pharmacovigilance group established
      to
      handle the processing of SAE reports to regulatory authorities and
      investigators. In addition to premarketed safety reporting, this group provides
      postmarketing spontaneous adverse event reporting. Our personnel have the
      training, education, and experience to provide a comprehensive range of safety
      reporting services to meet the demands of SAE reporting requirements of global
      drug/biologic/device investigational clinical programs and postmarketing
      surveillance programs.

     

    Cato
      Research has the flexibility to design unique processes for safety management;
      alternatively, sponsors may choose to follow Cato Research's SOPs that include
      use of Argus Safety and the medical coding dictionaries MedDRA and WHO Drug.
      Once the sponsor and Cato Research have agreed upon processes and templates,
      the
      pharmacovigilance group will create and document sponsor-specific work practices
      and forms. 

     

    Typically,
      pharmacovigilance will process an SAE report and produce an initial
      MedWatch/CIOMS form within 24 hours of notification of the SAE; narratives
      are routinely generated for each SAE report. The MedWatch form is then reviewed
      by the medical monitor, the clinical project team, and a medical coder before
      submission to the appropriate regulatory agencies.

     

    Electronic
      Data Capture

     

    For
      this
      study, Cato Research is assuming the use of a full-scale, electronic data
      capture (EDC) system and has provided a budget by using etrials® EDC
      software. Using EDC will allow Transdel to have live, up-to-date information
      on
      enrollment and study progress, including data entry and data queries. We have
      found that using EDC in studies reduces queries (through real time edit checks),
      speeds up data collection, helps identify data issues or trends early, and
      importantly, shortens time to database closure. However, if a site runs into
      accessibility issues, we can quickly convert to a hybrid system, where we can
      provide paper copies of the entry screens to the site, thereby allowing the
      site
      to fax the information back to Cato Research. Our qualified data-entry personnel
      will then enter these data directly into the electronic system. This approach
      still takes advantage of the online validations and real time data benefit.
      

     

    etrials
      has successfully conducted data management for over 900 studies encompassing
      all
      therapeutic areas across the globe. Cato Research and etrials have collaborated
      on many studies. For example, Cato Research recently initiated and managed
      a
      concentrated monitoring effort during the concluding months of a Phase 3
      neurology study involving 600 patients and 50 sites; we were able to
      close the database within a 1 day of the last patients’ final visit. In the
      2 weeks before database closure, 20 patients completed the study, and
      500 queries were resolved.

     

    In
      addition, etrials’ EDC system contains an ad hoc reporting tool that uses easy
      drag-and-drop features allowing users to design custom reports. Reports can
      contain any field in the database, can be saved for future use, and can be
      sent
      to or accessed by other users. Users can quickly obtain study information
      related to date of entry, query status, data modifications, and new entries
      in
      an easily accessible study reporting tool. Monitors can review subject data
      entered in the eCRF before they physically visit sites and can generate notes
      offsite that can be resolved by site staff before their site visits. Full
      tracking of all queries, including returned comments and final resolution,
      is
      contained within the EDC system. 

    
       

      
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                    Research Ltd.

                
	 	 


        

         

      

    

    Patient
      Diary

     

    A
      paper
      subject diary has been proposed to support the daily completion of visual analog
      pain scales by study subjects. Due to the cost-prohibitive nature of using
      electronic hand-held devices for subject diaries, we recommend using a paper
      diary for either paper-based data management or EDC. Cato Research understands
      that subjects will complete the patient diary three times each day for the
      seven
      days. Patients are to perform study drug self administration and record pain
      intensity in the subject diary. Once complete, these diaries will be returned
      to
      the study site and data will be entered by the site or Cato Research into the
      data management system. 

     

    Statistics
      and Medical Writing

     

    Cato
      Research has highly qualified and experienced statisticians and programmers
      who
      can create statistical analysis plans, conduct analyses, and assist in the
      preparation of reports for Phase 1 through Phase 4 studies. The statistical
      summary and data displays include data analyses, summaries, listings, and CRF
      tabulations that conform to the FDA or other regulatory agency guidelines for
      submissions. 

     

    Our
      statisticians, scientists, and physicians collaborate to provide high quality
      integrated clinical and statistical reports to provide a comprehensive overview
      of the trial and an integrated analysis of the clinical trial data. Our ICH
      E3-compliant report format was developed to facilitate review by regulatory
      agency personnel and includes in-text tables, figures, and convenient summaries
      that may be used by the FDA in the preparation of FDA reviewer documents.
      Numerous sponsors and FDA representatives have complimented Cato Research on
      the
      high quality and clarity of presentation of the Integrated Clinical and
      Statistical Reports produced by our project teams.

    
       

      
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              Part
                B

               

              Experience
                in Neurology Clinical Trials

               

            


    

     

    
      
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    Experience
      in Neurology Clinical Trials

     

    Cato
      Research has significant experience in all areas of analgesics development;
      our
      specific experience is outlined below:

     

    Experience
      in conducting pain management trials (acute and chronic)

    


    Cato
      Research has conducted multiple successful clinical studies for neurology
      indications, including pain management, in North America, Europe, and South
      Africa. Recent examples of Cato Research’s clinical experience in pain
      management studies include the following:

     

    
      
        	
              	·	
                Clinical
                  monitoring and management of three Phase 3 studies of chronic pain
                  conducted at over 275 sites in North America and
                  Europe

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring and management of a Phase 2b acute pain study in postoperative
                  subjects with approximate enrollment of 200 subjects across 40
                  sites in
                  the United States

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring and management of a 30-site Phase 2b study in Canada
                  for the
                  treatment of migraine pain

              


      

    

    
      
        	
              	
                ·

              	
                Full
                  service activities including clinical and data management of a
                  Phase 2
                  neuropathic pain study involving 100 subjects and
                  10 sites

              


      

    

    


    Not
      only
      does Cato Research have highly relevant clinical experience and therapeutic
      expertise, but we are also focused on having a flexible, proactive, and creative
      approach to managing clinical trials. At the start of any project, we work
      with
      the sponsor to determine project roles and responsibilities and how our staff
      can complement a sponsor’s existing resources. This approach can be especially
      valuable to smaller companies, particularly those that function primarily as
      virtual entities. 

     

    Related
      clinical trial experience in the past 3 years

    


    Phase
      2 and Phase 3 clinical trials

    


    Cato
      Research has conducted multiple successful Phase 2 and Phase 3 clinical trials
      in a variety of indications, including: acute and chronic pain (described
      above), depression, stroke, oncology, and infectious disease. Related experience
      includes: 

    
      
        	
              	·	
                Clinical
                  conduct of an 800-subject study in the United States of a selective
                  serotonin inhibitor targeted to treat major depressive
                  disorder

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring and management, data management, and statistical services
                  for a
                  Phase 2b study of ischemic stroke conducted at over 100 sites in
                  the
                  United States, Canada, South Africa, and
                  Europe

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring and management of a 35-subject Phase 2 safety and tolerability
                  study in Canada involving subjects with chronic hepatitis C
                  

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring, management, data management, and statistical services
                  for a
                  multicenter 60-subject Phase 2 study of HIV infection conducted
                  in the
                  United States 

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring, management, data management, and statistical services
                  for a
                  Phase 3 study of hepatitis C infection 

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring and management of a pivotal trial in 99 subjects with
                  familial
                  cold syndrome across 21 study centers in the United
                  States

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring and management of Phase 2, 3, and 3b trials involving
                  a
                  therapeutic for Alzheimer’s disease across 76 study centers and involving
                  a total of 554 subjects

              


      

    

    
      
        	
              	
                ·

              	
                Clinical
                  monitoring and management of a Phase 2 trial for an antidepressant
                  compound involving 240 subjects and 22 study sites
                  

              


      

    

     

    
       

      
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                  Research Ltd.

              
	 	 


      

    

     

    In
      addition to experience conducting Phase 2 and Phase 3 clinical trials, Cato
      Research has extensive experience with the preparation of documents associated
      with clinical trials, such as clinical protocols, clinical study reports,
      investigator’s brochures, study procedures manuals, monitoring plan, associated
      regulatory submissions, and CRFs (paper and electronic). We can also assist
      with
      organizing data and safety monitoring committees, as well as with investigator
      selection, investigator evaluation, and investigators’ meeting planning.


    


    Long-term
      safety studies

    


    Cato
      Research has conducted several long-term safety clinical trials for a number
      of
      indications, including chronic pain. Our experience with long-term safety
      studies includes the following:

    
      
        	
              	·	
                Management
                  of a 12-month, 1,200-subject, long-term safety study for chronic
                  pain
                  

              


      

    

    
      
        	
              	
                ·

              	
                Pharmacovigilance,
                  data management, and clinical trial management for a global Phase
                  3 study
                  with a very active safety focus for a novel therapeutic immunogen
                  (More
                  than 1,100 safety reports are currently stored in the Cato Research
                  database for this compound.) 

              


      

    

    
      
        	
              	
                ·

              	
                Management
                  of a Phase 3b schizophrenia study including monitoring, all regulatory
                  correspondence, clinical and nonclinical reports, and
                  pharmacovigilance

              


      

    

     

    
      
        	Strategies.
                Solutions. Success. TM	
                Page
                  12

              


      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    
      
         

        
          	CONFIDENTIAL	
                  Cato
                    Research Ltd.

                
	 	 


        

         

      

    

    
      	
               

              Part
                C

               

              Terms
                of Work

               

            


    

     

    
      
        	Strategies.
                Solutions. Success. TM	
                Page
                  13

              


      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    
       

      
        	CONFIDENTIAL	
                Cato
                  Research Ltd.

              
	 	 


      

       

    

    TERMS
      OF WORK

    


    In
      accordance with the Master Services Agreement between Transdel Pharmaceuticals
      Inc. (“Client”) and Cato Research Ltd. (“Cato Research”) dated as of 10 April
      2007 (the “Agreement”), Cato Research shall provide CRO Services to Client as
      outlined in the foregoing proposal. 

    


    The
      service fees and expenses set forth in this proposal are based on anticipated
      cooperation from Client’s personnel and third parties and on the assumption that
      unexpected circumstances will not be encountered while providing CRO Services.
      If the details of the required CRO Services change significantly from those
      outlined in Appendix 1, we will notify you and obtain approval before incurring
      additional service fees.

    


    The
      billing schedule will follow the format outlined in this proposal and all bills
      shall be issued and paid in accordance with the Agreement, except for payment
      terms of 90 days for the milestone payments of this proposal (unless otherwise
      noted) as outlined in Appendix 1 (all milestones will be invoiced upon
      completion). If the number of units performed exceeds the number of units in
      the
      budget, such additional units will be invoiced at the unit cost specified in
      the
      budget. In addition to the service fee, out of pocket expenses, pass-through
      costs and applicable taxes, if any, will be invoiced according to the Agreement
      and a 1.5% handling fee will be charged for all expenses and pass-through costs.
      If CRO Services are provided hereunder pursuant to a fixed service fee
      arrangement then, one year after the latest signature date below, and every
      year
      thereafter, the fee for all CRO Services for which Client is invoiced during
      the
      subsequent one year period shall increase by the greater of five percent (5%)
      or
      the rate of inflation as set forth in the Consumer Price Index - All Urban
      Consumers, All Items (1982-84=100) as of the last day of the previous
      month.

    


    The
      terms
      and conditions outlined in this proposal are governed by the Agreement and,
      once
      signed by both parties, may not be changed except in accordance with the
      Agreement. 

    


    By
      signing below, each party agrees that it has reviewed the specifications and
      CRO
      Service fee set forth in the proposal and agrees that Cato Research shall
      provide, and Client shall pay Cato Research for, the CRO Services described
      in
      the proposal.

    


    
      	Cato Research Ltd.	Transdel Pharmaceuticals
              Inc.
	 	 
	By: ____/s/
              Jo Cato____	By: __/s/
              Juliet Singh___________
	 	 
	Name: ___Jo
              Cato__________	Name: ___Juliet
              Singh_______
	 	 
	Title: __Managing
              Director___	Title: ___Chief
              Executive Officer___
	 	 
	Date: ____June
              10, 2008_____	Date: ____June
              10, 2008___


    

     

    
       

      
        	Strategies.
                Solutions. Success. TM	
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                  14